Roche: FDA Approves Gavreto To Treat Certain Types Of RET-altered Thyroid Cancer
Swiss drug maker Roche Group (RHHBY) announced Wednesday that the U.S. Food and Drug Administration has approved Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers.
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
The approval is for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection or RET-mutant medullary thyroid cancer or MTC who require systemic therapy.
The approval is also for patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Roche said these indications were approved under the FDA’s accelerated approval programme based on data from the phase I/II ARROW study. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The approvals are based on results from the phase I/II ARROW study, which demonstrated durable clinical activity in people with or without prior therapy and regardless of RET alteration genotypes.
Gavreto is now approved across multiple RET-altered tumour types.
In September, the FDA also granted accelerated approval to Gavreto to treat adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
In addition, the FDA granted Breakthrough Therapy Designation to Gavreto for the treatment of RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments and for RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy.
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